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    Summary
    EudraCT Number:2006-000755-18
    Sponsor's Protocol Code Number:AMENO2
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-04-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2006-000755-18
    A.3Full title of the trial
    Estudio Fase IV, Nacional, Multicéntrico, competitivo, aleatorizado, doble ciego, controlado de grupos paralelos, para determinar la seguridad, tolerabilidad, y eficacia de aprepitant, más palonosetrón frente a granisetrón en la prevención de las náuseas y la emesis inducidas por quimioterapia en pacientes tratados con trasplante de progenitores hematopoyéticos.

    A.4.1Sponsor's protocol code numberAMENO2
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación PETHEMA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name EMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAprepitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntiemético y antinauseoso
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Aloxi
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalonosetrón
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntagonista 5HT-3
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Kytril
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGranisetrón
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntagonista 5HT-3
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name EMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAprepitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntiemético y antinauseoso
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    náuseas y vómitos producidos en pacientes tratados con quimioterapia previa al transplante de progenitores hematopoyéticos
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Evaluar la hipótesis de que la profilaxis antiemética con Aprepitant y Palonosetron en combinación es más eficaz, en términos de pacientes con respuesta completa (pacientes sin emesis y sin administración de antieméticos de rescate), que la pauta estándar de granisetron para la prevención de las náuseas y vómitos inducidos por la quimioterapia del acondicionamiento (NVIQ) en el trasplante de progenitores hemopoyéticos (TPH).2. Evaluar la seguridad y tolerabilidad de la profilaxis antiemética con Aprepitant y Palonosetron en relación con la estándar de granisetrón.
    E.2.2Secondary objectives of the trial
    Como objetivos secundarios se pretende comparar: 1). La proporción de pacientes en cada una de las ramas con respuesta completa durante el primer día del acondicionamiento (fase aguda); 2). La proporción de pacientes en cada una de las ramas con respuesta completa desde el segundo día del acondicionamiento hasta la finalización del mismo (fase tardía); 3). La proporción de pacientes en cada una de las ramas sin náuseas significativas durante todo el periodo de acondicionamiento; 4). El tiempo a la aparición del primer vómito en cada una de las ramas; 5). El tiempo a la administración de la primera dosis de antieméticos de rescate en cada una de las ramas; 6). La intensidad de la emesis en cada una de las ramas.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Pacientes de edad igual o superior a 18 años
    -Que esé previsto realizarle al paciente un trasplante de progenitores hematopoyéticos conrégimen de acondionamiento de 5 días de duración como mínimo (con o sin radioterapia)
    -Las mujeres en edad fértil deben dar negativo en una prueba de embarazo en suero o en orina, sensible a 25 UI de B-hCG, en la visita anterior al estudio y acceder a utilizar un método anticonceptivo de doble barrera al menos desde los 14 días previos a la administración de la primera dosis del fármaco en estudio hasta como mínimolos 14 días siguientes a la última dosis.
    -El paciente tiene una puntuación de Karnofski ³ 60
    -El paciente tiene una esperanza de vida mayor o igual a un mes
    -El paciente es capaz de leer, entender y cumplimentar los cuestionarios del estudio, incluidas las preguntas que requieren respuesta en forma de escala analógica visual (EAV)
    -El paciente comprende los procedimientos del estudio y acepta participar en él, dando su consentimiento informado por escrito
    -El paciente recibe uno de estos cuatro regímenes de acondicionamiento:
    1. CBV (ciclofosfamida, BCNU y VP-16)
    2. BEAM (BCNU, VP-16, araC, melfalán)
    3. Regímenes con BUCY (busulfán x 4 días y ciclofosfamida más/menos otros agentes)
    4. CYTBI (ciclofosfamida más irradiación corporal total más/menos otros agentes)
    E.4Principal exclusion criteria
    a.Pacientes que se encuentren en cualquiera de las siguientes situaciones si, en opinión del investigador, éstas impiden su participación en el estudio:
    -Incapacidad mental o trastorno emoscional o psiquiátrico significativo.
    -El paciente consume actualmente algún tipo de droga, incluida la marihuana, o el investigador determina que tiene un consumo excesivo de alchohol en la actualidad.
    -El paciente padece alguna infección activa o cualquier enfermedad no controlada distinta al proceso maligno que, en opinión del investigador, podría confundir los resultados del estudio o hacer que la administración del fármaco en estudio suponga para el paciente un riesgo injustificado.
    -El paciente presenta antecedentes de Hipersensibilidad a granisetrón, palonosetrón o aprepitant.
    b.El paciente ha recibido algún fármaco no aprobado (en investigación) en las últimas 4 semanas.
    c.Antecedentes o historia actual de trastornos de la conducción cardíaca, en concreto del intervalo QTc. Uso de antiarrítmicos o presencia de trastornos electrolíticos capaces de dar lugar a trastornos de la conducción cardíaca.
    d.Valores de laboratorio anormales:
    AST mayor 2,5 x el límite superior a la normaidad
    ALT mayor 2,5 x el límite superior a la normalidad
    Bilirrubina mayor 1,5 x el límite superior a la normalidad
    Creatinina mayor 1,5 x el límite superior a la normalidad
    e.Pacientes que en las 48 horas previas al día 1 del estudio hayan sido tratados con los siguientes antieméticos:
    antagonistas de la 5-HT-3 (Ondasetrón, granisetrón, dolasetrón o tropisetrón)
    fenotiazinas (p. ej., proclorperazina, flufenazina, perfenazina, trietilperazina o clorpromazina)–
    butirofenonas (p. ej., haloperidol o droperidol)–
    benzamidas (p. ej., metoclopramida o alizaprida)–
    domperidona–
    cannabinoides
    f.Paciente que ha empezado a recibir tratamiento con benzodiazepinas o con opiáceos en las 48 horas previas al día 1 del estudio, excepto dosis únicas diarias de triazolam, temazepam, lorazepam y midazolam. Se autoriza la continuación del tratamiento crónico con benzodiazepinas o con opiáceos siempre que se haya iniciado al menos 48 horas antes del día 1 del estudio (considerando que pueden incrementarse sus niveles).
    g.El paciente está tomando o ha tomado en los 7 días previos al día 1 del estudio los siguientes sustratos de la CYP3A4:
    terfenadina
    cisaprida
    astemizol
    pimozida
    los siguientes inhibidores de la CYP3A4:–claritromicina (azitromicina, eritromicina y roxitromicina están permitidos)–ketoconazol o itraconazol (fluconazol se permite)
    h.El paciente está tomando o ha tomado en los 30 días previos al día 1 del estudio los siguientes sustratos de la CYP3A4:
    –barbitúricos
    –rifampicina o rifabutina
    –carbamazepina o fenitoina. Se permite la administración de fenitoina como profilaxis en regímenes con busulfán de corta duración, dado que: 1) Este es un regimen de acondicionamiento muy frecuente en el trasplante; 2) El corto periodo de tiempo de tratamiento conjunto –5 días como máximo- y 3) Con la recomendación de monitorizar los niveles de fenitoína (teniendo en cuenta que la mútua interacción entre aprepitant y fenitoína puede hacer disminuir los niveles de ambos).
    i.El paciente está tomando o ha tomado en los 7 días previos al día 1 del estudio esteroides (pueden administrarse como antiemético de rescate si así se indica).
    E.5 End points
    E.5.1Primary end point(s)
    Las variables de eficacia principales son:Tasa de respuesta completa (no vómitos, no tratamiento de rescate). También se evaluarán las tasas de “protección completa”, “control total”, pacientes “sin náuseas” y “sin náuseas importantes”, el tiempo hasta el primer vómito, el tiempo hasta la administración del primer antiemético de rescate y el impacto en la calidad de vida de la emesis determinada por la herramienta FLIE.
    Las variables de seguridad y tolerabilidad: La seguridad se evaluará utilizando los acontecimientos adversos y las pruebas clínicas de laboratorio que se realizarán a los pacientes basalmente, al finalizar el periodo de acontecimiento y un mes tras el TPH.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state196
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 196
    F.4.2.2In the whole clinical trial 196
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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